Covid19NCT04922944
Post COVID-19 Vaccination Analysis in Healthcare Worker Recipients
An observational study of Covid19 and Vaccine Reaction, run by Huntington Memorial Hospital at 1 site in United States.
Trial summary
This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Vaccine Reaction
- What is being tested?
- COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA who has completed the vaccination regimen
Who may be able to join
- Signed informed consent for study
- Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA, (must have valid hospital identification)
- Must have completed vaccination regimen (two doses if required) no more than 8 weeks ± 5 days before enrollment
- Must have completed, valid vaccination card, if vaccinations received at a center other than Huntington Hospital
- Able to read English, sign consent form and complete on-line surveys
Who cannot join
- Huntington Hospital employees on leave of absence
- Anyone not able/willing to provide blood specimens and respond to surveys for the 52-week study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Vaccination Antibody Assays and Reactions in Hospital Employees and Medical Staff: an Analysis of Antibody Response Over Time
This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. The immunity will be evaluated over time by measuring serum semi-quantitative SARS-Co-V2 IgG from blood specimens and analyzing vaccine reaction data. SARS-CoV-2 is the name for the virus responsible for COVID-19 infections. IgG, immunoglobulin G, is an antibody found in the blood that protects against bacterial and viral infections. Study subjects will also be asked to report physical reactions they may have experienced related to vaccinations.
Read the detailed description
As some of the first recipients of SARS-CoV-2 vaccines under emergency authorization use, healthcare workers represent a diverse subpopulation, that are now moving through the immune response to the Pfizer and Moderna mRNA vaccines. As individual responses may vary, this provides an opportunity to evaluate levels of IgG response in relation to age, gender, comorbidities and other factors that may influence immunity. We recognize that, though this is only part of the immune response that may be protective for severe COVID-19 disease, it is a first step in understanding the level and durability of post vaccination SARS-CoV-2 antibodies.
This small, pilot study will evaluate the immune response over time by measuring serum semi-quantitative SARS-CoV-2 IgG from healthcare vaccinees at various timepoints. A high-level review of reactions related to the vaccinations will be performed with the same population of healthcare workers.
- Conditions
- Covid19, Vaccine Reaction
- Being tested
- COVID-19 vaccine
- Keywords
- SARS-CoV-2, vaccination, antibody formation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccineDrug
Also called Pfizer-BioNTech COVID-19 vaccine, Moderna COVID-19 vaccine
Two-dose COVID-19 vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SARS-CoV-2 IgG Titer Over Time
Semi-quantitative SARS-CoV-2 IgG titer
Measured: 8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion
Secondary outcomes (2)
Occurrence of post-vaccine reactions
Subjective reporting of occurrence of post-vaccination reactions including anaphylactic reactions (such as difficulty breathing, swelling of face and throat, fast heartbeat, bad rash all over body, and dizziness and weakness); injection site pain; injection site swelling/hardness; injection site redness; tiredness; headache; muscle pain; chills; join pain; fever; nausea; feeling unwell; and/or swollen lymph nodes
Measured: Within 3 days after vaccine injections
Severity of post-vaccine reactions
Subjective reporting of severity of post-vaccine reactions (none, mild, moderate, or severe)
Measured: Within 3 days after vaccine injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start8 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huntington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Shriner, MD, Principal investigator, Huntington Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922944
- Sponsor's protocol ID
- Pro00050032
- Status last verified
- Sep 2024
- First submitted
- 30 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Vaccination Antibody Assays and Reactions in Hospital Employees and Medical Staff: an Analysis of Antibody Response Over Time
- ClinicalTrials.gov ID
- NCT04922944
- Acronym / sponsor ID
- Pro00050032
- Conditions
- Covid19, Vaccine Reaction
- Keywords
- SARS-CoV-2, vaccination, antibody formation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Huntington Memorial HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying how healthcare worker recipients react after receiving vaccinations for COVID-19. The objective of the study is to evaluate the immune response to COVID-19 vaccination. The immunity will be evaluated over time by measuring serum semi-quantitative SARS-Co-V2 IgG from blood specimens and analyzing vaccine reaction data. SARS-CoV-2 is the name for the virus responsible for COVID-19 infections. IgG, immunoglobulin G, is an antibody found in the blood that protects against bacterial and viral infections. Study subjects will also be asked to report physical reactions they may have experienced related to vaccinations.
Detailed description
As some of the first recipients of SARS-CoV-2 vaccines under emergency authorization use, healthcare workers represent a diverse subpopulation, that are now moving through the immune response to the Pfizer and Moderna mRNA vaccines. As individual responses may vary, this provides an opportunity to evaluate levels of IgG response in relation to age, gender, comorbidities and other factors that may influence immunity. We recognize that, though this is only part of the immune response that may be protective for severe COVID-19 disease, it is a first step in understanding the level and durability of post vaccination SARS-CoV-2 antibodies.
This small, pilot study will evaluate the immune response over time by measuring serum semi-quantitative SARS-CoV-2 IgG from healthcare vaccinees at various timepoints. A high-level review of reactions related to the vaccinations will be performed with the same population of healthcare workers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA who has completed the vaccination regimen
Key inclusion criteria (5 listed)
- Signed informed consent for study
- Current employee or active member of the medical staff of Huntington Hospital, Pasadena, CA, (must have valid hospital identification)
- Must have completed vaccination regimen (two doses if required) no more than 8 weeks ± 5 days before enrollment
- Must have completed, valid vaccination card, if vaccinations received at a center other than Huntington Hospital
- Able to read English, sign consent form and complete on-line surveys
Key exclusion criteria (2 listed)
- Huntington Hospital employees on leave of absence
- Anyone not able/willing to provide blood specimens and respond to surveys for the 52-week study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccineAlso: Pfizer-BioNTech COVID-19 vaccine, Moderna COVID-19 vaccineTwo-dose COVID-19 vaccine | Drug | – |
Primary outcome
Change in SARS-CoV-2 IgG Titer Over Time
Time frame: 8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion
Semi-quantitative SARS-CoV-2 IgG titer
2 secondary outcomes
Occurrence of post-vaccine reactions
Time frame: Within 3 days after vaccine injections
Severity of post-vaccine reactions
Time frame: Within 3 days after vaccine injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Shriner, MD principal investigator
Huntington Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Vaccine Reaction, run by Huntington Memorial Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SARS-CoV-2 IgG Titer Over Time (time frame: 8 weeks (± 5 days) post-vaccination regimen completion; 24 weeks (± 5 days) post-vaccination regimen completion; and 52 weeks (± 5 days) post-vaccination regimen completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.